(399 days)
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.
The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader. The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician. The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor). The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: ID-Cap System
Predicate Device: Ingestion Event Marker (IEM) Data recorder (Patch) (K150494 - Proteus Digital Health Feedback Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" as a separate, quantitative table. Instead, it presents a comparison with a predicate device and implicitly sets performance targets based on the predicate's performance and the device's intended function. The "Comments" column in Table 5 functions as a statement of equivalence or acceptable difference.
Here's a re-organized table focusing on the performance metrics presented, drawing implications of acceptance from the comparison:
| Metric | Acceptance Criteria (Implied from Predicate/Safety) | Reported ID-Cap System Performance |
|---|---|---|
| Clinical Performance | ||
| Positive Detection Accuracy (PDA) | Comparable to predicate (97.2% with 95% CI) to ensure reliable detection of ingestion events. | 95.0% (Similar PDA to predicate) |
| Negative Detection Accuracy (NDA) | 100% (95% CI) as demonstrated by predicate, indicating no false positive ingestion events. | 100% (95% CI) (Similar NDA to predicate) |
| Unanticipated Adverse Device Effects | None, demonstrating device safety. | None (Similar to predicate) |
| Severe Adverse Events (related to System) | None, demonstrating device safety. | None (Similar to predicate) |
| Discontinuations due to AEs | Lower or equal to predicate (2.8% due to skin irritation), ideally zero for non-skin contact device. | None (Improved over predicate, as skin irritation risk is mitigated by design) |
| Ingestible Sensor AEs | Comparable incidence and severity to predicate (5.7% of subjects, 0% of ingestions, mostly mild) to ensure acceptable safety profile. | 10.2% of subjects (100% mild in severity) in pooled safety analysis; Incidence of at least one related AE is 0.6% of ingestions. (Similar w.r.t. incidence and severity of AEs reported for device use) |
| Data Recorder AEs | Lower or equal to predicate (17.7% of subjects reporting skin irritation), ideally none since it's not a skin-contact device. | None (Improved over predicate, as skin irritation risk is mitigated by design) |
| Proper Excretion of ID-Tags | All ID-Tags should be excreted without retention. | Confirmed by post-ingestion X-rays showing non-retention. |
| Technological Characteristics (Non-Clinical) | ||
| Time to Detect | Comparable to predicate's activation time, allowing for the dissolution of the capsule. Predicate: 1.0 minute mean. | 6.4 minutes (mean) for ID-Tag encapsulated in ID-Capsule in direct observation clinical study. (Longer than predicate due to capsule dissolution, but acceptable given longer signal duration). |
| Duration of Detected Signal | Sufficiently long to ensure reliable detection. Predicate: 7.29 minutes mean. | 27.9 minutes (mean) from first detection in direct observation clinical study. (Longer than predicate). |
| Biocompatibility | All patient-contacting materials (ingestible sensor, reader where applicable) must be biocompatible and non-toxic per ISO 10993 standards and risk assessment. | Tested per ISO 10993-1, including cytotoxicity, sensitization, irritation, pyrogenicity, implantation, acute/subacute systemic toxicity, and chemical characterization. All found biocompatible and non-toxic. |
| Electrical Safety | Compliance with IEC 60601-1 standards. | Tested to IEC 60601-1:2005 (3rd Edition) & IEC 60601-1-11:2015. Passed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standards. | Tested to IEC 60601-1-2:2014 (4th Edition and home use levels) & JIS T 0601-1-2 (12th Edition 2012). Passed. |
| Wireless Coexistence | Acceptable performance in wireless coexistence scenarios. | Tested to ANSI C63.27 2017 Wireless Coexistence. Acceptable. |
| Spectrum Compatibility & RF Safety | Compliance with relevant regulations (FCC and Industry Canada). | FCC and Industry Canada Grant of Authorization received. Acceptable. |
| Mechanical Performance | Passed impact resistance tests and other mechanical strength requirements. | Tested per IEC 60601-1:2005 (3rd Edition) & IEC 60601-1-11:2015, and other applicable tests. Acceptable. |
| Shelf-Life | Verified shelf-life for capsules and acceptable aging performance for Readers. | Shelf-life testing performed for ID-Capsules, and shelf-life/aging analysis performed for Readers. Acceptable. |
| Human Factors & Usability | Demonstrate ease of use and safety for intended user groups (patients and clinicians). | Summative usability validation study conducted with two user groups (patient and clinician). Results supported design, function, appropriate use, and performance. Acceptable. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not explicitly stated as a single number for a "test set." The clinical studies included participants (18 – 79 years old, mean 41.9 years, stratified by gender and BMI). The specific number of ingestions or unique patients contributing to the PDA/NDA calculations is not provided, only the resulting percentages.
- Data Provenance: Retrospective or prospective is not explicitly stated. However, the mention of "clinical studies" and "direct observation clinical study" implies prospective clinical data collection. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. The ground truth for this device (ingestion detection) appears to be established by direct observation in clinical settings, rather than expert review of independent data (like image annotations by radiologists). The device's function is to detect an event that is directly observable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device. The "ground truth" for ingestion is likely established by direct clinician observation or participant logging combined with the device's own detection, not by independent adjudication of outputs from a black-box system.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
Not applicable. This device is an ingestible event marker, not an AI-powered diagnostic imaging tool that assists human readers. Its primary function is automated detection, not interpretation requiring human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the core performance metrics (Positive Detection Accuracy, Negative Detection Accuracy, Time to Detect, Duration of Detected Signal) are presented as standalone algorithm performance (the ID-Cap System's ability to detect ingestion events). The device is designed for "unattended data collection," indicating a standalone operational mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for ingestion events was established through direct observation in clinical studies. For example, the "Time to Detect" and "Duration of Detected Signal" metrics were derived from a "direct observation clinical study." Proper excretion was confirmed by post-ingestion X-rays.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "performance testing" section refers to clinical studies and bench testing, not an ML model's training data.
9. How the ground truth for the training set was established
Not applicable, as this is not a machine learning model. Performance validation was done through clinical studies and extensive engineering/bench testing against established standards and internal requirements.
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December 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
etectRx, Inc. Paul Dryden Consultant 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, Florida 32601
Re: K183052
Trade/Device Name: ID-Cap System Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW Dated: November 26, 2019 Received: November 27, 2019
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
ID-Cap System
Indications for Use (Describe)
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule,
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
JOver-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
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| Official Contact: | Susan Baumgartner, PharmD, MBAVP, Product Management & Regulatory AffairsetectRx, Inc.747 SW 2nd Ave Suite365T, IMB 24Gainesville, FL 32601Tel – (352) 443-5713 x110 |
|---|---|
| Proprietary or Trade Name: | ID-Cap System |
| Common/Usual Name: | Ingestible event marker |
| Classification Name: | 21 CFR 880.6305OZW – Ingestible event marker ClassII |
| Predicate Devices: | K150494 – Ingestion Event Marker (IEM) Datarecorder (Patch) |
Device Description
The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader.
The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician.
The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor).
The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
Indications for Use
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events signaled by the co-incidence with or coingestion with the ID-Capsule, is desirable.
Comparison of ID-Cap System to Predicate
We present in Tables 1 - 5 a comparison of the subject device compared to the predicate.
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Table 1 – Comparison - High-Level System
| PredicateK150494 | Subject Device | Comments | |
|---|---|---|---|
| Trade Name | Proteus Digital Health Feedback Device | ID-Cap System | Identical |
| Classification | Ingestible Event Marker(21 CFR 880.6305) | Ingestible Event Marker(21 CFR 880.6305) | |
| Product Code | OZW, DXH | OZW | Product code DXH is not relevant forthe subject device, since the subjectdevice does not include a telephoneelectrocardiograph transmitter andreceiver. |
| System Components | Ingestion Event Marker (IEM)Data recorder (Patch)Software | ID-Capsule (with ID-Tag)ID-Cap ReaderSoftware | Similar components. An ingestiblesensor, a wearable data recorder, andsoftware |
| Indications for Use | The Proteus Digital Health FeedbackDevice consists of a miniaturized,wearable sensor for ambulatory recordingof physiological and behavioral metricssuch as heart rate, activity, body anglerelative to gravity (body position), andtime-stamped patient logged events,including events signaled by the co-incidence with, or co-ingestion with, theingestible sensor accessory. When theingestible sensor is ingested, the ProteusDigital Health Feedback Device isintended to log, track and trend intaketimes. When co-ingested with medication,the tracking and trending of intake timesmay be used as an aid to measuremedication adherence. The ProteusDigital Health Feedback Device may beused in any instance where quantifiable | The ID-Cap System consists of awearable reader for ambulatoryrecording of events signaled byswallowing the ID-Capsule whichcontains the ID-Tag, an ingestible sensor.The ID-Cap System is intended to log,track, and trend intake times and enablesunattended data collection for clinicalapplications. The ID-Cap System may beused in any instance where quantifiableanalysis of ingestion events, includingevents signaled by the co-incidence withor co-ingestion with the ID-Capsule, isdesirable. | The indications for use of the subjectdevice are a subset of the indicationsfor use of the predicate. |
| Predicate | Subject Device | Comments | |
| K150494 | |||
| analysis of event-associated physiologicaland behavioral metrics is desirable andenables unattended data collection forclinical and research applications. | |||
| Patient Population | Based on current labeling, clinical studyvolunteers were 21–85 years old (mean:44.6 years). | Clinical study participants were 18 – 79years old (mean 41.9 years), stratified bygender and BMI. | Similar |
| Environment of Use | Ambulatory useUnattended data collection for clinicaland research applicationsDo not wear during airplane travelIntended for use in specifiedelectromagnetic environment | Ambulatory useUnattended data collection for clinicaland research applicationsNot intended for use on aircraftIntended for use in specifiedelectromagnetic environment | IdenticalNeither is designed for use in aircraft |
| Prescription use | Yes | Yes | Identical |
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Table 2 – Comparison - Technological Characteristics – Ingestible Sensor
| PredicateK150494 | ID-Cap System | Comments | |
|---|---|---|---|
| Name | Ingestion Event Marker | ID-Capsule (capsule containing the ID-Tag, an ingestible sensor) | |
| Ingestible Sensor | Integrated circuit (IC) with attached 5mm diameter x 300µm semi-rigidinsulating skirt disk (excipient skirt) | ID-Tag is a 22.5 mm x 9.5 mm x 60microns (L x W x H) flexible substratewith printed antenna, attached IC andcapacitor | Different physical characteristics ofingestible sensor - Both are ICsmounted on a small, thin substrate. |
| Basic Technology | Bio-galvanically powered ingestiblecircuit | Bio-galvanically poweredingestible circuit | Similar |
| Method of SignalCommunication | Volume conduction communicationHigh frequency AC (alternatingcurrent) | Very low power digital radio frequency(RF) messages | Different method of signalcommunication, but fundamentally alow-powered signal |
| Electrical Power Source | Differential metal contacts (Mg-CuCl)activated by electrolytes in stomachfluidMineral biogalvanic | Differential metal contacts (Mg-AgCl)activated by electrolytes in stomach fluidMineral biogalvanic | Similar means of powering but usingdifferent metal technology |
| Activation | When wet in stomach | When wet in stomach | Similar activation |
| Time to Detect | 1.0 minute (mean) in directobservation clinical study | 6.4 minutes (mean) for ID-Tagencapsulated in ID-Capsule in directobservation clinical study | The capsule takes ~ 6 minutes todissolve vs. the predicate which is notencapsulated; however, the duration ofdetected signal is longer for the subjectdevice. |
| Duration of Detected Signal | 7.29 minutes (mean) in directobservation clinical study | 27.9 minutes (mean) from first detectionin direct observation clinical study | Subject device has a longer duration ofdetection |
| Signaling Control | 1 mm x 1 mm x 0.3 mmcomplementary metal-oxidesemiconductor (CMOS) IC | 1 mm x 1 mm x 0.3 mm complementarymetal-oxide semiconductor (CMOS) IC | Similar |
| Oral Delivery Vehicle | Ingestible sensor is attached to an inertpharmaceutical excipient tablet | Ingestible sensor is encapsulated in astandard pharmaceutical capsule shell | Similar – Oral delivery vehicles forboth are inert and listed in the FDAinactive ingredient database |
| PredicateK150494 | ID-Cap System | Comments | |
| Swallowable Size andWeight | Round pillSize: 6.5 mm x 2.0 mmWeight: 80 mg | CapsuleSize and weight below for size 00 gelatincapsuleSize:Locked length = 23.5 mmCap diameter = 8.56 mmBody diameter = 8.21 mmWeight: 24.3 mg | The subject device is delivered in astandard pharmaceutical capsule shell,while the predicate is a tabletconfiguration. |
| Patient-ContactingMaterial | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Testing per ISO 10993, and all patient-contacting materials foundbiocompatible |
| Data Transmitted from theSensor | Digital signaling information,including unique ID for the ingestiblesensor | Digital signaling information consisting ofRF signals with encoded digital data | Similar data transmitted. See rowbelow for unique ID discussion. |
| Unique ID for Sensor | Each sensor is encoded with a uniqueID which is recorded by the patch. | The ID-Tag sends RF messages to theReader which assigns a unique ingestionevent ID number to the ID-Tag messagesreceived. | Unique ID is generated within theReader vs. pre-assigned to theingestible sensor.Simultaneous ingestions of multipleID-Capsules are not recommended withthe subject device. |
| Excretion | Chip excreted via GI tract | ID-Tag excreted via GI tract | SimilarSafety demonstrated in clinical studieswith post-ingestion X-ray confirmationof non-retention of ID-Tags. |
| Maximum Number ofIngestions per Day | Do not exceed more than 30 ingestionsper day. | No more than five ingestions per day, witha minimum of 90 minutes between ID-Capsule ingestions to ensure that each ID-Tag is appropriately identified and eachingestion event is detected. | Single ingestions with a minimum of90 minutes between ingestions for thesubject device. |
| PredicateK150494 | ID-Cap System | Comments | |
| Common name | Proteus Personal Monitor (Patch) | ID-Cap Reader | |
| Data Recorder Description | Adhesive patch worn on the skin | Pendant hanging from a lanyard wornaround the neck | The subject device Reader is notattached to the patient's skin. |
| Function | Receives, stores, and wirelessly sendsingestion confirmation data to ageneral computing device | Receives, stores, and wirelessly sendsingestion confirmation data to a generalcomputing device | Similar |
| Form Factor | Body-worn sensor attached to the skinwith an adhesive patch | Pendant hanging in front of the chestfrom a lanyard placed loosely around theneck | Similar, except predicate is anadhesive patch placed on the patient'sskin |
| Memory and Data Storage | Stores dataOvoid patch 4 MB or 16 MB;Rectangular patch 16 MB | Stores data8 MB | SimilarStorage capacity is adequate for theintended use. |
| Size | One-Piece Ovoid Patch:102 mm x 60 mm x 9.8 mm or102 mm x 60 mm x 6.3 mmTwo-Piece Rectangular Patch:98 mm x 42 mm x 11 mm | 97 mm x 47 mm x 23 mm | Similar - Both are small and wearable.The subject device can be easily takenoff between ingestions. |
| Weight | Ovoid Patch 10 g or 11 gRectangular Patch 16 g | 78 g | |
| Battery Type | Lithium Manganese (LiMn) Coin Cell | Rechargeable Lithium Polymer | Similar - The subject device is arechargeable unit, whereas thepredicate is a one-time use, disposableunit. |
| Battery Life | Data recording for 5-7 days | Rechargeable battery designed to last atleast 36 hours on a full charge;Qi-compliant wireless charger includedwith Reader | Similar – Battery life is adequate forintended use. |
| Data Reception | Wireless, skin contact required | Wireless, skin contact not required | Subject device does not require skincontact. |
| PredicateK150494 | ID-Cap System | Comments | |
| Data Recorded | Time-stamped, patient-logged events,including events signaled byswallowing the Ingestion EventMarker (IEM) accessoryRecords digital ID and date and timeof ingestion confirmationRecords heart rate, activity, body anglerelative to gravity (body position),temperature, heart rate variability,respiratory rate, and inter-electrodeimpedance | Time-stamped, patient-logged events,including events signaled by swallowingthe ID-CapsuleRecords assigned ingestion event IDnumber and date and time of ingestionconfirmationNo physiological metrics collectedRecords Reader status and channelcommunication information | The ingestion event marking is similar.The subject device does not capturephysiological metrics. |
| Device Monitoring | Inter-electrode impedance helpsdetermine proper wearing of patch fordetection | Reader messages communicate devicestatus.Accelerometer (motion detection)provides insight into patient use ofReader and whether user is wearing it. | The subject device Reader is lessposition and placement dependent thanthe predicate device. |
| Manual Event Logging | Manually press an event marker buttonon the PatchSensor technology: patient-activatedbuttonMethod: digital pulse | Not on the ID-Cap Reader, but availablein the ID-Cap App | The subject device does not have amanual event logging feature itself;however, the ID-Cap App does. |
| Data Communication | Wirelessly sends data to a generalcomputing device via Bluetooth | Wirelessly sends data to a generalcomputing device via Bluetooth LowEnergy (BLE) protocol | Similar methods |
| User Interface | Patch button initiates communicationto mobile computing deviceManual event marker buttonIndicator light | Single on/off/standby button - onceturned on, device is ready for useTri-color LED indicator light | Similar - Simple user interface |
| Reusable Components /Disposal | Single-use only | Reusable | The subject device Reader is reusable. |
| PredicateK150494 | ID-Cap System | Comments | |
| Biocompatibility and Toxicity Testing | |||
| Biocompatibility andToxicity -Data Recorder(Reader) | Patch is attached to the patient's skinTested and demonstrated to bebiocompatible and non-toxic | Reader has no direct attachment to thepatientTested and demonstrated to bebiocompatible and non-toxic | ISO 10993 testing performed includes:cytotoxicity, sensitization, andirritation testing. |
| Biocompatibility andToxicity - Ingestible Sensor | Ingestible sensor demonstrated to bebiocompatible and non-toxic | Ingestible sensor demonstrated to bebiocompatible and non-toxic | ISO 10993 testing performed includes:cytotoxicity, sensitization, irritation,pyrogenicity, implantation, acutesystemic toxicity, and subacutesystemic toxicity. |
| Additional biocompatibilitytesting | Chemical characterization with risk-based toxicity assessment | Chemical characterization with risk-based toxicity assessment | Testing and assessment performed |
| Electrical Safety, EMC, and Battery Testing | |||
| Electrical Safety | IEC 60601-1 | IEC 60601-1:2005 (3rd Edition) IEC60601-1-11:2015 | Tested to applicable standards andpassed |
| ElectromagneticCompatibility | IEC 60601-1-2 | IEC 60601-1-2:2014 (4th Edition andhome use levels)JIS T 0601-1-2 (12th Edition 2012) | Tested to applicable standards andpassed |
| Wireless CoexistencePerformance | Tested | ANSI C63.27 2017 WirelessCoexistence | Testing performed and acceptable |
| Spectrum Compatibilityand RF Safety | N/A | FCC and Industry Canada Grant ofAuthorization received - relevantRules Parts and Radio SystemsSpecifications | Testing performed and acceptable |
| Mechanical and Electrical Performance | |||
| Impact Resistance | Passed | IEC 60601-1:2005 (3rd Edition) IEC60601-1-11:2015 | Testing performed and resultsacceptable |
| Performance of AntennaUsed in IEM | Mechanical strengthResidual solvent of disc materialFriabilityElectrical properties of disc | Mechanical strengthN/AN/AElectrical properties | Applicable testing performed andresults acceptable |
| PredicateK150494 | ID-Cap System | Comments | |
| Non-Clinical PerformanceTesting of Ingestible Sensor | Tested for activation time and lifetimeafter activation | Tested for activation time and lifetimeafter activation | Applicable testing performed andresults acceptable |
| Signal ReceptionPerformance of DataRecorder | High frequency (HF) and lowfrequency (LF) signal chainperformance tests | Reader bench testing | Applicable testing performed andresults acceptable |
| System PerformanceTesting | Device performance for event markingin simulated bench testing and clinicaltesting | Device performance for event markingin simulated bench testing and clinicaltesting | Similar |
| Proper Excretion of Device | Animal testing | Post-ingestion X-rays in clinicalstudies | Human testing performed withX-ray confirmation of non-retentionfor the subject device. |
| Shelf-Life | Testing referenced in labeling | Shelf-life testing performed for ID-Capsules, and shelf-life/aging analysisperformed for Readers. | Applicable testing performed andresults acceptable |
| Human Factors and Usability Evaluation | |||
| Human Factors/Usability | Testing performed | Testing performed with two usergroups: patient users and clinicianusers | Human factors/usability testingperformed and results acceptable |
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Table 3 – Comparison - Technological Characteristics – Data Recorder
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Table 4 – Comparison of Performance Testing
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| PredicateK150494 | ID-Cap System | Comments | |
|---|---|---|---|
| Clinical Studies of Safety and Performance – Key Measures | |||
| Positive DetectionAccuracy (PDA) | 97.2% (95% CI)cumulative average | 95.0% | Similar PDA |
| Negative DetectionAccuracy (NDA) | 100% (95% CI)cumulative average | 100% (95% CI) | Similar NDA |
| Maximum dailyingestions in clinicalstudies | 34 IEMs | 5 ID-Capsules | Subject device is notdesigned for multipleingestible sensoringestions simultaneously;therefore, fewer total dailyingestions are possible. |
| Unanticipated adversedevice effects | None | None | Similar |
| Severe adverse eventsrelated to or possiblyrelated to the System | None | None | Similar |
| Discontinuations dueto AEs | 2.8% of subjectsdiscontinued due to skinirritation | None | Subject device does nothave direct skin contact;thus, this risk is mitigated. |
| Ingestible sensor AEs | 5.7% of subjects(overall non-serious AEs- 92% mild and 8%moderate in severity)0% of ingestions | 10.2% of subjects(100% mild in severity)in pooled safetyanalysisIncidence of at least onerelated AE is 0.6% ofingestions | Similar with respect toincidence and severity ofadverse events reportedwith use of the device inclinical studies. |
| Data recorder AEs | 17.7% of subjectsreported localized skinirritation andinflammation with patch | None | Subject device designmitigates this risk. |
Table 5 - Comparison of Clinical Performance
Discussion of the Comparison and Differences
As presented in Tables 2 - 5, we have compared the etectRx ID-Cap System ("ID-Cap System") to the predicate, Proteus Digital Health Feedback Device ("Proteus" cleared under K150494) for equivalence of:
Indications, Patient Population and Environment of Use – The ID-Cap System is seeking similar indications for use as a device which is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. It may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ingestible sensor, is desirable.
The patient population and environment of use are similar.
Discussion – The indications for use of the subject device are a subset of the indications for use of the predicate. These differences do not raise new or different risk concerns than the predicate; thus, they are substantially equivalent.
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Prescription-Use Only - Both devices are prescription-use only.
Discussion - There is no difference in the type of device as a prescription device; thus, they are substantially equivalent.
Design, Technology and Principle of Operation – The fundamental design, technology, and principle of operation of a bio-galvanically powered ingestible circuit that, when activated by stomach fluid, sends a wireless signal to a data recorder is similar between the subject device and predicate.
The subject device generates a unique ID for the ingestion event when the Reader detects the first signal from the ingested sensor, whereas the predicate sensor is pre-assigned a unique ID that is then transmitted to the data recorder (i.e., patch).
Discussion - The subject ID-Capsule which encapsulates the ID-Tag is a standard pharmaceutical capsule shell which dissolves, allowing the ID-Tag to be activated. The time to activation is longer than the predicate as the capsule must first dissolve, but the time available to detect the output signal from the ID-Tag is significantly longer.
The subject device Reader receives the RF signal with no requirement for direct skin contact, while the predicate requires the data recorder (i.e., patch) to be attached to a specific location over the stomach and adhere properly to the patient's skin in order to receive the signal via conduction.
The information transmitted for the subject device relates only to the ingestion event and Reader status. The subject device does not collect, send, or track physiological metrics like the predicate.
The difference of how the unique ID is provided still results in each ingestion event being recorded and tracked under a unique ID.
These differences do not raise different risk concerns than the predicate; thus, they are substantially equivalent.
Performance -
Non-Clinical Testing Summary -
Biocompatibility - In following the Special Controls, ISO 10993-1 testing was performed as appropriate for the respective patient-contacting materials in the ingestible sensor and the data recorder.
Discussion - The test results demonstrated that the patient-contacting materials were biocompatible.
Bench Testing
The subject device has been tested for performance and compliance as it relates to electrical safety, EMC, wireless coexistence, shelf-life, mechanical performance, ingestible sensor performance, Reader detection performance, and system performance to ensure that all requirements have been met.
Discussion - The subject device met its performance requirements. Any differences did not raise new or different concerns about safety or effectiveness, and, thus, the subject device can be considered substantially equivalent to the predicate.
Human Factors/Usability - As required under the Special Controls, we performed Human Factors / Usability testing. We identified the applicable user groups and conducted a summative usability validation study. The results supported the design, function, appropriate use, and performance of the subject device for the intended use population.
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Clinical Testing Summary -
The clinical trials performed demonstrates that the ID-Cap System does not raise different questions of safety and effectiveness. These clinical trials included evaluations of the following parameters:
- Positive Detection Accuracy (PDA) ●
- . Negative Detection Accuracy (NDA)
- . Effect of gender and BMI on PDA
- Time to detection of ingestion ●
- Duration of detected signal
- . Time to phone receipt and time to server receipt following ingestion of the ID-Capsule
- Adverse events ●
- Proper excretion of ID-Tags as evidenced by post-ingestion X-rays showing non-retention of ID-Tags ●
Substantial Equivalence Conclusion
The ID-Cap System is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, specifications / performance, and clinical evaluations.
The differences, as detailed above, do not raise different risks of safety and effectiveness. Thus, the subject device can be considered substantially equivalent to the predicate device.
§ 880.6305 Ingestible event marker.
(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.